NDC 53045-270 Ionite H

Stannous Fluoride

NDC Product Code 53045-270

NDC 53045-270-04

Package Description: 122 g in 1 TUBE

NDC Product Information

Ionite H with NDC 53045-270 is a a human over the counter drug product labeled by Dharma Research, Inc.. The generic name of Ionite H is stannous fluoride. The product's dosage form is gel, dentifrice and is administered via dental form.

Labeler Name: Dharma Research, Inc.

Dosage Form: Gel, Dentifrice - A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Ionite H Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • STANNOUS FLUORIDE .4 mg/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)
  • XYLITOL (UNII: VCQ006KQ1E)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Dental - Administration to a tooth or teeth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Dharma Research, Inc.
Labeler Code: 53045
FDA Application Number: part355 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 08-02-2015 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Ionite H Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Stannous fluoride, 0.4%

Purpose

Anticavity

Uses

Aids in the prevention of dental cavities (caries).

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Warnings

Supervision of children is required when using this product.  Developing teeth of children under six years of age may become permanently discolored if excessive amounts are repeatedly swallowed.

Directions

• This is not a toothpaste. Read directions carefully before using.• Adults and children 6 years of age and older:   o Use once per day after brushing teeth thoroughly with toothpaste   o Twist off cap to remove foil seal   o Apply a small amount to a toothbrush and brush thoroughly on all tooth surfaces.   o Allow the gel to remain on your teeth for 1 minute   o Spit out. Do not swallow   o Do not eat, drink, or rinse for at least 30 minutes• Children under 6: consult a dentist or doctor

Other Information

  • Store at room temperature 59 – 86°F (15 – 30°C)This product may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist

Inactive Ingredients

Carbopol, citric acid, flavor, glycerin, sodium hydroxide, water, xylitol

Other

Manufactured by Dharma Research, Inc.www.dharmaresearch.com5220 N.W. 72 Avenue, Unit 15Miami, FL 331661-877-833-3725

Ionite H

NDC 53045-270-04Home Care0.4% Stannous Fluoride Gel with XylitolAnticavity Fluoride Preventative Treatment GelSpearmintMade in USAGluten Free Dye FreeReorder#: 56-001304.3 oz. (122 g)

* Please review the disclaimer below.